SHANDONG INT MEDICAL INSTRUMENTS CO., LTD

FDA Device Registration & Listing · Rizhao Shandong, CN · Registration 3034544377

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034544377
FEI Number
3034544377
Entity Name
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD
City/State/Country
Rizhao Shandong, CN
Establishment Address
No. 188, Fuzhou Road, Rizhao city, Shandong, China., Rizhao Shandong 276803, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shandong INT Medical Instruments Co., Ltd (Owner Number: 10091928)
Owner / Operator Contact Address
No. 188, Fuzhou Road, Rizhao city, Shandong, China., Rizhao, CN-SD 276803, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K244038
PMA Number
N/A

All Registered Proprietary Names

Inflation Device Angiography Injector Pressure Bandage High Pressure Tubing

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2025-09-02
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2025-01-13
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2024-12-08
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2025-09-07

Official Correspondent

Jeffrey Hui

US Agent Details

Diana Alpin Email: info@duocarepro.com Phone: (626) 4923094

Related Public Records

Same Entity

Shandong INT Medical Instruments Co., Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2008 Lemaitre Vascular, Inc. 2
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05 Medrad Inc 2
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Similar Registrations

Registration Number Establishment Name Location
3016931787 BRUN MEDICAL CO., LTD. Zhuzhou Hunan, CN
3018182863 SUZUYO CO., LTD Yokohama Kanagawa, JP
1921846 Cardinal Health Hazelwood, MO, US
3007361214 SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. Shenzhen Guangdong, CN
3006223010 GENOSS Co., Ltd. Suwon-si Gyeonggi, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034544377. Last updated year: 2026. Please use registration number 3034544377 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.